Zhang Yong-Qing, Liang Rong, Bai Qing-Xian, Zhang Tao, Yang Lan, Wang Yi-Wei, Wang Wen-Qing, Gu Hong-Tao, Shu Mi-Mi, Zhu Hua-Feng, Bai Yan-Ni, Chen Xie-Qun
Department of Hematology, Xijing Hospital, the Fourth Military Medical University, Xi'an 710032, China.
Zhonghua Xue Ye Xue Za Zhi. 2009 Apr;30(4):260-3.
To investigate the efficacy and safety of PAD [bortezomib (PS-341), doxorubicin and dexamethasone] regimen for relapsed or refractory multiple myeloma (MM).
Seventeen patients with relapsed or refractory MM received two to four 21-day cycles of PAD: an intravenous bolus of bortezomib (1.3 mg/m2) on days 1, 4, 8, and 11; doxorubicin 10 mg per day on days 1 to 4, and dexamethasone 40 mg on days 1-4. Response was evaluated according to International Myeloma Working Group Criteria (IMWG 2006), toxicity was graded according to NCI CTCAE (common terminology criteria for adverse events) v 3.0.
After 2-4 courses of PAD, 14 patients (82.4%) response, including complete response (CR) in 4 (23.5%), very good partial response (VGPR) in 4 (23.5%), partial response (PR) in 6 (35.3%) and stable disease (SD) in 3 (17.6%). Median time to progression was 9.5 months. The median course to response was 1.6 (1-3). All of 5 patients with extramedullary plasmacytoma achieved at least PR after the first cycle therapy; the plasmacytoma disappeared after 1-2 cycles of PAD. The efficacy was independent of other prognostic factors such as beta2-MG. Adverse events included thrombocytopenia in 9 patients (52.9%), leukopenia in 4 (23.5%), peripheral neuropathy in 4 (23.5%), varicella herpes zoster in 3 (17.6%), fatigue in 6 (35.3%) and diarrhea in 2 (11.7%). All of these adverse reactions could be controlled with routine supportive treatment, only one patient died from respiratory failure during his fifth PAD cycle.
PAD regimen should be considered as an appropriate treatment for relapsed or refractory MM, especially for MM with extramedullary plasmacytoma. Its efficacy is independent of traditional prognostic factors. The side effects are usually manageable.
探讨PAD方案（硼替佐米（PS - 341）、阿霉素和地塞米松）治疗复发或难治性多发性骨髓瘤（MM）的疗效和安全性。
17例复发或难治性MM患者接受2至4个21天周期的PAD方案治疗：第1、4、8和11天静脉推注硼替佐米（1.3mg/m²）；第1至4天阿霉素每日10mg，第1至4天地塞米松40mg。根据国际骨髓瘤工作组标准（IMWG 2006）评估反应，根据美国国立癌症研究所不良事件通用术语标准（NCI CTCAE）v 3.0对毒性进行分级。
2至4个疗程的PAD治疗后，14例患者（82.4%）有反应，包括4例（23.5%）完全缓解（CR）、4例（23.5%）非常好的部分缓解（VGPR）、6例（35.3%）部分缓解（PR）和3例（17.6%）病情稳定（SD）。中位进展时间为9.5个月。中位缓解疗程为1.6（1 - 3）。5例髓外浆细胞瘤患者在第一个周期治疗后均至少达到PR；1至2个周期的PAD治疗后浆细胞瘤消失。疗效与β2 - MG等其他预后因素无关。不良事件包括9例（52.9%）血小板减少、4例（23.5%）白细胞减少、4例（23.5%）周围神经病变、3例（17.6%）水痘带状疱疹、6例（35.3%）疲劳和2例（11.7%）腹泻。所有这些不良反应均可通过常规支持治疗得到控制，仅1例患者在第5个PAD周期死于呼吸衰竭。
PAD方案应被视为复发或难治性MM，尤其是伴有髓外浆细胞瘤的MM的合适治疗方案。其疗效与传统预后因素无关。副作用通常可控制。
